Regulatory Operations Manager CRM
Regulatory Operations Manager CRM
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$ 120800 - 181200
1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses: Cardiac Pacing Therapies Defibrillation Solutions Patient Management and Procedure Innovations. Together we will transform the lives of people with cardiac arrhythmias and heart failure.At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
This role is based in Mounds View MN.
The Regulatory Operations Manager leads a team responsible for regulatory submission publishing product lifecycle management master data administration change control support audit readiness and other regulatory activities. This role combines operational expertise with strategic leadership to drive efficiency quality compliance and team development in global regulatory processes.
Key Responsibilities
Team Leadership and Development:
Prioritize strategic and departmental initiatives define performance goals and objectives conduct performance reviews and hold regular 1:1s to guide employee development and performance management.
Foster a culture of collaboration accountability and continuous improvement within the team.
Collaborate with Regulatory peers within our function and across other Operating Units (OUs) to support and drive the successful implementation of new initiatives and ensure business continuity.
Regulatory Operations:
Oversee the preparation compilation and publishing of regulatory submissions including license renewals and annual registrations ensuring compliance with global standards.
Ensure accurate and efficient management of product lifecycle data and master data systems to support regulatory and business needs.
Lead regulatory aspects of change control processes ensuring timely and compliant implementation.
Oversee planning of submission related post-market costs of the department budget; approve spending within defined limits.
Represent Regulatory on Enterprise-wide initiatives keeping senior management within our OU and those that we support informed of new developments and any issues.
Audit Support and Compliance:
Support internal and external audits by ensuring documentation processes and systems are audit-ready and compliant with applicable regulations and standards.
Maintain up-to-date knowledge of global regulatory requirements and ensure team activities align with those regulations guidelines and standards.
Process Optimization and Systems Management:
Identify and implement process improvements to enhance efficiency and compliance in regulatory operations.
Optimize the use of electronic systems templates and reporting capabilities to streamline operations and improve outcomes.
Training and Collaboration:
Develop and support training programs to enhance team expertise in regulatory processes tools and systems.
Collaborate with internal stakeholders and external vendors to ensure seamless operations and alignment on submission and compliance objectives.
Data Analysis and Reporting:
Monitor and analyze data from diverse systems to support tracking reporting and decision-making related to regulatory operations compliance initiatives and process improvements.
Must Have; Minimum Requirements
To be considered for this role please ensure the minimum requirements are evident in your applicant profile.
Requires a Baccalaureate and minimum of 5 years business operations experience
Or advanced degree with a minimum of 3 years business operations experience.
Nice To Have
Medical device industry experience
Knowledge of regulatory submissions product lifecycle management change control processes and audit readiness.
Proven leadership experience with ability to mentor develop and manage teams.
Analytical skills and proficiency in electronic document management systems and reporting tools.
Excellent problem-solving process improvement and communication skills.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Manager
Employment Type
Full-Time
